Trial Outcomes & Findings for Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) (NCT NCT00566527)
NCT ID: NCT00566527
Last Updated: 2018-01-30
Results Overview
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1620 participants
Primary outcome timeframe
Day 132 (6 weeks after ProQuad® Dose 2)
Results posted on
2018-01-30
Participant Flow
Pediatric participants from 9 to 12 months of age at the start of the study were recruited at 48 study centers in Finland, France, and Germany.
Participant milestones
| Measure |
Arm 1: ProQuad® at 9 and 12 Months
Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
|
Arm 2: ProQuad® at 11 and 14 Months
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Overall Study
STARTED
|
541
|
540
|
539
|
|
Overall Study
Received ProQuad® Dose 1
|
529
|
484
|
470
|
|
Overall Study
Received ProQuad® Dose 2
|
525
|
478
|
462
|
|
Overall Study
COMPLETED
|
524
|
474
|
461
|
|
Overall Study
NOT COMPLETED
|
17
|
66
|
78
|
Reasons for withdrawal
| Measure |
Arm 1: ProQuad® at 9 and 12 Months
Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
|
Arm 2: ProQuad® at 11 and 14 Months
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Overall Study
Reason not provided
|
3
|
11
|
10
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
8
|
20
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
43
|
43
|
Baseline Characteristics
Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
Baseline characteristics by cohort
| Measure |
Arm 1: ProQuad® at 9 and 12 Months
n=541 Participants
Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
|
Arm 2: ProQuad® at 11 and 14 Months
n=540 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=539 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Total
n=1620 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.47 Months
STANDARD_DEVIATION 0.29 • n=5 Participants
|
9.48 Months
STANDARD_DEVIATION 0.30 • n=7 Participants
|
9.47 Months
STANDARD_DEVIATION 9.43 • n=5 Participants
|
9.48 Months
STANDARD_DEVIATION 0.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
821 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
259 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
799 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 132 (6 weeks after ProQuad® Dose 2)Population: All baseline seronegative participants with immunogenicity data are included.
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=445 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=443 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Measles
|
98.0 Percentage of participants
Interval 96.2 to 99.1
|
98.8 Percentage of participants
Interval 97.3 to 99.6
|
—
|
|
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Mumps
|
99.5 Percentage of participants
Interval 98.4 to 99.9
|
99.5 Percentage of participants
Interval 98.3 to 99.9
|
—
|
|
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Rubella
|
99.3 Percentage of participants
Interval 98.0 to 99.9
|
99.5 Percentage of participants
Interval 98.4 to 99.9
|
—
|
|
Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Varicella
|
100.0 Percentage of participants
Interval 98.8 to 100.0
|
100.0 Percentage of participants
Interval 98.9 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Day 132 (6 weeks after ProQuad® Dose 2)Population: All baseline seronegative participants with immunogenicity data are included.
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=500 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=443 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Mumps
|
99.2 Percentage of participants
Interval 97.9 to 99.8
|
99.5 Percentage of participants
Interval 98.3 to 99.9
|
—
|
|
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Rubella
|
99.4 Percentage of participants
Interval 98.3 to 99.9
|
99.5 Percentage of participants
Interval 98.4 to 99.9
|
—
|
|
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Varicella
|
100.0 Percentage of participants
Interval 98.2 to 100.0
|
100.0 Percentage of participants
Interval 98.9 to 100.0
|
—
|
|
Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2
Measles
|
94.9 Percentage of participants
Interval 92.6 to 96.7
|
98.8 Percentage of participants
Interval 97.3 to 99.6
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)Population: All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=528 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=480 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=466 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Reactions
Injection-site erythema
|
14.4 Percentage of participants
Interval 11.5 to 17.7
|
15.4 Percentage of participants
Interval 12.3 to 19.0
|
17.2 Percentage of participants
Interval 13.9 to 20.9
|
|
Percentage of Participants With Solicited Injection-site Adverse Reactions
Injection-site pain
|
11.4 Percentage of participants
Interval 8.8 to 14.4
|
10.4 Percentage of participants
Interval 7.8 to 13.5
|
13.7 Percentage of participants
Interval 10.7 to 17.2
|
|
Percentage of Participants With Solicited Injection-site Adverse Reactions
Injection-site swelling
|
2.3 Percentage of participants
Interval 1.2 to 3.9
|
4.6 Percentage of participants
Interval 2.9 to 6.9
|
2.4 Percentage of participants
Interval 1.2 to 4.2
|
PRIMARY outcome
Timeframe: Up to Day 28 (up to 28 days after ProQuad® Dose 1)Population: All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.
The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=528 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=480 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=466 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions
|
24.8 Percentage of participants
Interval 21.2 to 28.7
|
23.3 Percentage of participants
Interval 19.6 to 27.4
|
19.1 Percentage of participants
Interval 15.6 to 23.0
|
PRIMARY outcome
Timeframe: Up to Day 28 (up to 28 days after ProQuad® Dose 1)Population: All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.
The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=528 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=480 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=466 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1
|
72.0 Percentage of participants
Interval 67.9 to 75.8
|
71.9 Percentage of participants
Interval 67.6 to 75.9
|
71.9 Percentage of participants
Interval 67.6 to 75.9
|
PRIMARY outcome
Timeframe: Up to Day 28 (up to 28 days after ProQuad® Dose 1)Population: All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.
The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=528 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=480 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=466 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C
|
8.8 Percentage of participants
Interval 6.5 to 11.5
|
10.3 Percentage of participants
Interval 7.7 to 13.4
|
14.8 Percentage of participants
Interval 11.7 to 18.4
|
SECONDARY outcome
Timeframe: Day 42 (6 weeks after ProQuad® Dose 1)Population: All participants with seronegative baselines who received ProQuad® Dose 1 and have immunogenicity data available are included.
Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre \<255 mIU/mL; mumps antibody titre \<10 ELISA Ab units mL; rubella antibody titre \<10 IU/mL; and varicella antibody titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=518 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=460 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=447 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Measles (mIU/mL)
|
942 GMT
Interval 808.0 to 1098.0
|
1977 GMT
Interval 1736.0 to 2252.0
|
2500 GMT
Interval 2199.0 to 2841.0
|
|
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Mumps (ELISA Ab units/mL)
|
73 GMT
Interval 68.0 to 79.0
|
91 GMT
Interval 84.0 to 99.0
|
86 GMT
Interval 79.0 to 93.0
|
|
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Rubella (IU/mL)
|
64 GMT
Interval 60.0 to 70.0
|
77 GMT
Interval 71.0 to 83.0
|
81 GMT
Interval 75.0 to 88.0
|
|
Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1
Varicella (gpELISA units/mL)
|
15 GMT
Interval 13.0 to 16.0
|
15 GMT
Interval 14.0 to 16.0
|
15 GMT
Interval 14.0 to 16.0
|
SECONDARY outcome
Timeframe: Day 132 (6 weeks after ProQuad® Dose 2)Population: All participants with seronegative baselines who received ProQuad® Dose 2 and have immunogenicity data available are included.
Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre \<255 mIU/mL; mumps antibody titre \<10 ELISA Ab units mL; rubella antibody titre \<10 IU/mL; and varicella antibody titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=500 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=445 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=443 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Measles (mIU/mL)
|
1817 GMT
Interval 1645.0 to 2006.0
|
2320 GMT
Interval 2129.0 to 2529.0
|
2703 GMT
Interval 2492.0 to 2933.0
|
|
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Mumps (ELISA Ab units/mL)
|
157 GMT
Interval 147.0 to 168.0
|
163 GMT
Interval 151.0 to 175.0
|
172 GMT
Interval 159.0 to 185.0
|
|
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Rubella (IU/mL)
|
106 GMT
Interval 99.0 to 113.0
|
116 GMT
Interval 109.0 to 124.0
|
118 GMT
Interval 111.0 to 126.0
|
|
GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2
Varicella {gpELISA units/mL)
|
431 GMT
Interval 372.0 to 500.0
|
460 GMT
Interval 410.0 to 517.0
|
515 GMT
Interval 466.0 to 569.0
|
SECONDARY outcome
Timeframe: Day 132 (6 weeks after ProQuad® Dose 2)Population: All participants who received ProQuad® and have serology results are included.
The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=523 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=474 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=459 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL
ProQuad® Dose 1
|
99.8 Percentage of participants
Interval 98.9 to 100.0
|
100.0 Percentage of participants
Interval 99.2 to 100.0
|
99.8 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL
ProQuad® Dose 2
|
100.0 Percentage of participants
Interval 99.3 to 100.0
|
100.0 Percentage of participants
Interval 99.2 to 100.0
|
100.0 Percentage of participants
Interval 99.2 to 100.0
|
SECONDARY outcome
Timeframe: Day 42 (6 weeks after ProQuad® Dose 1)Population: All baseline seronegative participants with immunogenicity data are included.
The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=518 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=460 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=447 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
Measles
|
72.6 Percentage of participants
Interval 68.5 to 76.5
|
87.9 Percentage of participants
Interval 84.6 to 90.8
|
90.2 Percentage of participants
Interval 87.0 to 92.8
|
|
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
Mumps
|
96.6 Percentage of participants
Interval 94.6 to 98.0
|
98.7 Percentage of participants
Interval 97.1 to 99.5
|
98.3 Percentage of participants
Interval 96.6 to 99.3
|
|
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
Rubella
|
97.7 Percentage of participants
Interval 96.0 to 98.8
|
98.9 Percentage of participants
Interval 97.5 to 99.6
|
98.0 Percentage of participants
Interval 96.2 to 99.1
|
|
Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1
Varicella
|
95.0 Percentage of participants
Interval 91.2 to 97.5
|
97.8 Percentage of participants
Interval 95.4 to 99.1
|
97.5 Percentage of participants
Interval 95.2 to 98.8
|
SECONDARY outcome
Timeframe: Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)Population: All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.
The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=528 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=480 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=466 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Measles-like rash
|
4.0 Percentage of participants
Interval 2.5 to 6.0
|
5.8 Percentage of participants
Interval 3.9 to 8.3
|
6.9 Percentage of participants
Interval 4.7 to 9.6
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Rubella-like rash
|
1.3 Percentage of participants
Interval 0.5 to 2.7
|
1.9 Percentage of participants
Interval 0.9 to 3.5
|
1.5 Percentage of participants
Interval 0.6 to 3.1
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Varicella-like rash
|
5.3 Percentage of participants
Interval 3.6 to 7.6
|
4.0 Percentage of participants
Interval 2.4 to 6.1
|
6.4 Percentage of participants
Interval 4.4 to 9.1
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Zoster-like rash
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1
Mumps-like illness
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.4 Percentage of participants
Interval 0.1 to 1.5
|
SECONDARY outcome
Timeframe: Day 132 (6 weeks after ProQuad® Dose 2)Population: All participants who received ProQuad® Dose 2 and have safety follow-up data available are included.
The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.
Outcome measures
| Measure |
Arm 2: ProQuad® at 11 and 14 Months
n=524 Participants
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=474 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=462 Participants
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Measles-like rash
|
2.1 Percentage of participants
Interval 1.1 to 3.7
|
2.7 Percentage of participants
Interval 1.5 to 4.6
|
2.8 Percentage of participants
Interval 1.5 to 4.8
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Rubella-like rash
|
1.5 Percentage of participants
Interval 0.7 to 3.0
|
1.9 Percentage of participants
Interval 0.9 to 3.6
|
0.9 Percentage of participants
Interval 0.2 to 2.2
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Varicella-like rash
|
2.1 Percentage of participants
Interval 1.1 to 3.7
|
3.8 Percentage of participants
Interval 2.3 to 5.9
|
2.6 Percentage of participants
Interval 1.3 to 4.5
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Zoster-like rash
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2
Mumps-like illness
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
Arm 1: ProQuad® at 9 and 12 Months
Serious events: 21 serious events
Other events: 468 other events
Deaths: 0 deaths
Arm 2: ProQuad® at 11 and 14 Months
Serious events: 15 serious events
Other events: 430 other events
Deaths: 0 deaths
Arm 3: ProQuad® at 12 and 15 Months
Serious events: 17 serious events
Other events: 401 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: ProQuad® at 9 and 12 Months
n=541 participants at risk
Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
|
Arm 2: ProQuad® at 11 and 14 Months
n=540 participants at risk
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=539 participants at risk
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Bronchiolitis
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Bronchitis
|
0.37%
2/541 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.74%
4/540 • Number of events 5 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.56%
3/539 • Number of events 3 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Exanthema subitum
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
3/541 • Number of events 3 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.56%
3/540 • Number of events 3 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.37%
2/539 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Gastroenteritis Norwalk virus
|
0.37%
2/541 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.1%
6/541 • Number of events 6 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.37%
2/540 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.56%
3/539 • Number of events 3 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Influenza
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Nasopharyngitis
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Otitis media
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.56%
3/539 • Number of events 3 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.37%
2/540 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Pyelonephritis acute
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Sepsis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.37%
2/539 • Number of events 2 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Viral infection
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.74%
4/539 • Number of events 4 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/539 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Nervous system disorders
Convulsion
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Nervous system disorders
Febrile convulsion
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.18%
1/541 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/540 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/541 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.19%
1/540 • Number of events 1 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
0.00%
0/539 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
Other adverse events
| Measure |
Arm 1: ProQuad® at 9 and 12 Months
n=541 participants at risk
Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
|
Arm 2: ProQuad® at 11 and 14 Months
n=540 participants at risk
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
|
Arm 3: ProQuad® at 12 and 15 Months
n=539 participants at risk
Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
66/541 • Number of events 71 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
11.5%
62/540 • Number of events 77 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
11.5%
62/539 • Number of events 72 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Gastrointestinal disorders
Teething
|
8.1%
44/541 • Number of events 65 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
5.2%
28/540 • Number of events 39 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
4.8%
26/539 • Number of events 32 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
37/541 • Number of events 44 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
4.8%
26/540 • Number of events 31 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
4.3%
23/539 • Number of events 28 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
General disorders
Injection site erythema
|
51.4%
278/541 • Number of events 383 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
48.5%
262/540 • Number of events 350 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
43.2%
233/539 • Number of events 322 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
General disorders
Injection site pain
|
18.3%
99/541 • Number of events 126 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
18.5%
100/540 • Number of events 123 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
20.2%
109/539 • Number of events 137 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
General disorders
Injection site swelling
|
19.8%
107/541 • Number of events 117 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
16.7%
90/540 • Number of events 100 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
15.2%
82/539 • Number of events 92 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
General disorders
Irritability
|
14.2%
77/541 • Number of events 127 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
13.0%
70/540 • Number of events 103 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
16.0%
86/539 • Number of events 113 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
General disorders
Pyrexia
|
17.0%
92/541 • Number of events 117 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
17.0%
92/540 • Number of events 133 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
14.1%
76/539 • Number of events 99 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Ear infection
|
7.4%
40/541 • Number of events 44 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
4.4%
24/540 • Number of events 28 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
5.0%
27/539 • Number of events 31 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Gastroenteritis
|
5.2%
28/541 • Number of events 29 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
5.6%
30/540 • Number of events 30 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
2.8%
15/539 • Number of events 16 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
51/541 • Number of events 58 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.8%
42/540 • Number of events 51 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
6.9%
37/539 • Number of events 42 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Otitis media
|
8.3%
45/541 • Number of events 53 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
8.5%
46/540 • Number of events 50 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.6%
41/539 • Number of events 48 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Rhinitis
|
18.7%
101/541 • Number of events 127 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
17.4%
94/540 • Number of events 110 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
13.9%
75/539 • Number of events 99 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
70/541 • Number of events 85 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
12.6%
68/540 • Number of events 87 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
14.1%
76/539 • Number of events 98 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Psychiatric disorders
Crying
|
6.7%
36/541 • Number of events 43 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
3.1%
17/540 • Number of events 29 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
3.5%
19/539 • Number of events 27 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
61/541 • Number of events 68 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
8.3%
45/540 • Number of events 52 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.4%
40/539 • Number of events 44 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.3%
34/541 • Number of events 38 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
4.8%
26/540 • Number of events 28 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
5.6%
30/539 • Number of events 40 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
52/541 • Number of events 64 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
6.9%
37/540 • Number of events 47 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.6%
41/539 • Number of events 48 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
5.9%
32/541 • Number of events 33 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.2%
39/540 • Number of events 41 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.6%
41/539 • Number of events 45 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
6.5%
35/541 • Number of events 39 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
6.3%
34/540 • Number of events 40 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
7.2%
39/539 • Number of events 43 • Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sanofi Pasteur MSD shall have sixty days to review these documents and may refuse to give its consent in part or whole for confidential reasons (including but not limited to intellectual property rights, whether patentable or not).
- Publication restrictions are in place
Restriction type: OTHER